Flawed packaging was cited in nearly 400 Class II and III other FDA recalls between 2010-2012.

Numbers don’t lie.

If your job is to manage packaging controls and QA/QC, the first step is to identify if you’ve got a problem. The second is to take the steps required to fix it. This presenation will feature tips and tricks such as:

How to navigate myriad packaging standards that only increase each year

How to identify the most important flaws or shortcomings in your medical device packaging program

How to show an FDA inspector that you understand the agency’s packaging requirements

Understand what FDA audit spots investigators are focusing on during device inspections

How to learn from the mistakes of others to apply proven risk-based decision-making when developing a stronger device packaging program

What FDA investigators consider when they’re debating if it’s time to recall your product

Learning Objectives

In just 90 minutes, you’ll receive a deep understanding of how packaging engineering is often overlooked, how the FDA is auditing packaging and best practices to use cost-effective risk management to improve compliance.

Medical device manufacturing and executives

QA/QC managers and directors

Production managers

Production supervisors

Quality inspection and test managers

Purchasing managers

Supply chain specialists

Process development staff

Compliance officers

Training managers

Regulatory affairs and compliance professionals

Engineering and design controls teams

Executive management

General/corporate counsel

Personnel new to the industry

Risk management specialists

Strategic planning and business development staff

Validation specialists, scientists, engineers

Abhishek (Abhi) Gautam, Manager of Packaging Engineering, ConMed
Abhi is a packaging engineer with 12 years of experience in medical device sector (orthopedics, cardiovascular and surgical) and currently works as Packaging Engineering Manager at ConMed Corporation. With his strong exposure to a complex matrix of quality and regulatory function with respect to the medical device (terminally sterilized) packaging industry, he has gained significant insight and knowledge. He is currently pursuing a Graduate Certificate in Strategic Management from Harvard University. He also holds a MS degree (Packaging Science) from Rochester Institute of Technology, Rochester, NY and a BE degree (Printing Technology) from India. He has written multiple articles and presented multiple times and enjoys contributing to the medical device packaging industry. He is also a co-inventor on several ground breaking patents in the field of packaging design and application.